Anterior Cruciate Ligament Tear
Conditions
Brief summary
The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.
Detailed description
Enrolled patients will be randomized to either the Bridge-Enhanced ACL Repair (BEAR) technique (new treatment) or an ACL reconstruction (current gold standard of treatment).
Interventions
DEVICEBEAR Scaffold
A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament.
PROCEDURETendon Graft
A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee)
Sponsors
Miach Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 14 to 35 years of age. * Sex: Both male and female * ACL: Complete tear * Time from injury to surgery: ≤45 days * MRI: ACL tissue present on pre-operative MRI - at least 50% of the ACL length must still be attached to the tibial plateau
Exclusion criteria
* Prior surgery on affected knee * Prior joint infection on affected knee * Regular use of tobacco or nicotine * Use of corticosteroid within last 3 months * History of chemotherapy treatment * History of sickle cell disease * History of anaphylaxis * Any condition that could affect healing or infection risk (Diabetes, inflammatory arthritis, etc) * Operative posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament) * Grade III medial collateral ligament injury * Complete patellar dislocation * Known allergy to bovine, beef or cow products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Instrumented Anteroposterior (AP) Laxity Testing | 2 years after surgery | This is a test of how stable the knee is. The anteroposterior (AP) knee laxity will be determined using a KT arthrometer at the 30lb (130N) setting on both knees of the subject at six months and 1, 2, 6 and 10 years after surgery (see Appendix C). Both sides will be covered with a sleeve so the licensed examiner cannot tell which is the operated knee or which procedure the patient had. Values for both knees will be recorded. For knee laxity, a difference of 2.0 mm in the side-to-side difference measurements at 2 years after surgery, the primary analysis, for the patients in the bridge-enhanced repair group vs. the ACL reconstruction group will be considered clinically significant. |
| International Knee Documentation Committee (IKDC) Subjective | 2 years after surgery | This is a survey taken by patients to report how their knee is working for them. The IKDC is graded by adding the results and converting the result to a number on a scale from 0 to 100. Scores range from 0 (lowest level of function and highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prone Hamstring Strength at 6 Months | 6 months | Measured by a hand-held dynamometer on both the involved and contralateral knees, measured as injured knee as percent of non injured knee. The subject lies on their stomach and flexes their leg. The trainer puts the dynamometer near the ankle in the direction of extension. The subject pushes as hard as they can in the flexion direction, against the dynamometer. Ratio is calculated as the measurement of injured knee over measurement of non-injured knee. |
| Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months. | 6 months | This is a survey taken by patients to report how confident they are in returning to sports after the injury. The 12 questions on the ACL-RSI scale ask about the psychological effects of returning to sports. The ACL-RSI items are graded using an NRS (numeric rating scale) from 0 to 10. It has three domains: risk appraisal, confidence, and emotions. A total score between 0 and 100 is calculated by adding and averaging the scores for each item. Greater psychological preparation is indicated by higher scores. |
Countries
United States
Participant flow
Pre-assignment details
The protocol enrollment is the number of participants who had surgery, not the number of participants who were evaluated at baseline.
Participants by arm
| Arm | Count |
|---|---|
| Bridge-Enhanced ACL Repair (BEAR) The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into.
BEAR Scaffold: A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament. | 65 |
| Tendon Graft ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL.
Tendon Graft: A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) | 35 |
| Total | 100 |
Baseline characteristics
| Characteristic | Bridge-Enhanced ACL Repair (BEAR) | Tendon Graft | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 43 Participants | 21 Participants | 64 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 14 Participants | 36 Participants |
| Age, Continuous | 19.5 years STANDARD_DEVIATION 5.2 | 19.8 years STANDARD_DEVIATION 5.3 | 19.6 years STANDARD_DEVIATION 5.2 |
| Body Mass Index (BMI) | 24.7 kg/m^2 STANDARD_DEVIATION 3.8 | 23.5 kg/m^2 STANDARD_DEVIATION 4.6 | 24.3 kg/m^2 STANDARD_DEVIATION 4.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants | 35 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 56 Participants | 27 Participants | 83 Participants |
| Sex: Female, Male Female | 37 Participants | 19 Participants | 56 Participants |
| Sex: Female, Male Male | 28 Participants | 16 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 35 |
| other Total, other adverse events | 34 / 65 | 11 / 35 |
| serious Total, serious adverse events | 16 / 65 | 5 / 35 |
Outcome results
Primary
Instrumented Anteroposterior (AP) Laxity Testing
This is a test of how stable the knee is. The anteroposterior (AP) knee laxity will be determined using a KT arthrometer at the 30lb (130N) setting on both knees of the subject at six months and 1, 2, 6 and 10 years after surgery (see Appendix C). Both sides will be covered with a sleeve so the licensed examiner cannot tell which is the operated knee or which procedure the patient had. Values for both knees will be recorded. For knee laxity, a difference of 2.0 mm in the side-to-side difference measurements at 2 years after surgery, the primary analysis, for the patients in the bridge-enhanced repair group vs. the ACL reconstruction group will be considered clinically significant.
Time frame: 2 years after surgery
Population: Multiple imputation used for missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge-Enhanced ACL Repair (BEAR) | Instrumented Anteroposterior (AP) Laxity Testing | 1.7 mm | Standard Deviation 3.2 |
| Tendon Graft | Instrumented Anteroposterior (AP) Laxity Testing | 1.8 mm | Standard Deviation 2.8 |
Primary
International Knee Documentation Committee (IKDC) Subjective
This is a survey taken by patients to report how their knee is working for them. The IKDC is graded by adding the results and converting the result to a number on a scale from 0 to 100. Scores range from 0 (lowest level of function and highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time frame: 2 years after surgery
Population: Multiple imputation used for missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge-Enhanced ACL Repair (BEAR) | International Knee Documentation Committee (IKDC) Subjective | 88.6 score on a scale | Standard Deviation 13.4 |
| Tendon Graft | International Knee Documentation Committee (IKDC) Subjective | 84.6 score on a scale | Standard Deviation 13.3 |
Secondary
Prone Hamstring Strength at 6 Months
Measured by a hand-held dynamometer on both the involved and contralateral knees, measured as injured knee as percent of non injured knee. The subject lies on their stomach and flexes their leg. The trainer puts the dynamometer near the ankle in the direction of extension. The subject pushes as hard as they can in the flexion direction, against the dynamometer. Ratio is calculated as the measurement of injured knee over measurement of non-injured knee.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge-Enhanced ACL Repair (BEAR) | Prone Hamstring Strength at 6 Months | 93.3 percentage of non injured knee | Standard Deviation 23.6 |
| Tendon Graft | Prone Hamstring Strength at 6 Months | 59.1 percentage of non injured knee | Standard Deviation 21.3 |
Secondary
Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months.
This is a survey taken by patients to report how confident they are in returning to sports after the injury. The 12 questions on the ACL-RSI scale ask about the psychological effects of returning to sports. The ACL-RSI items are graded using an NRS (numeric rating scale) from 0 to 10. It has three domains: risk appraisal, confidence, and emotions. A total score between 0 and 100 is calculated by adding and averaging the scores for each item. Greater psychological preparation is indicated by higher scores.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge-Enhanced ACL Repair (BEAR) | Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months. | 71.5 score on a scale | Standard Deviation 19.5 |
| Tendon Graft | Return to Sport (RSI) Patient Reported Outcomes Score at 6 Months. | 58.9 score on a scale | Standard Deviation 24.1 |